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NCT01942772 Clinical Trial

A Powered Ankle Foot Rehabilitation Orthosis

Stroke Clinical Trial

Official title:
Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01942772
Other study ID # byang421
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 27, 2013
Last updated September 11, 2013
Start date January 2013

Study information
Verified date March 2013
Source Beijing Institute of Technology
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2
Est. completion date
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- ankle joint injuries about dorsiflexion and plantar flexion

- Ability to keep balance independently

Exclusion Criteria:

- ankle joint injuries about varus and valgus rehabilitation

- two assistants needed while walking

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Ankle-Foot Orthosis

Locations
Country Name City State
China Beijing Institute of Technology Beijing Beijing

Sponsors (2)
Lead Sponsor Collaborator
Beijing Institute of Technology China Rehabilitation Research Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary good performance of the ankle foot orthosis Two researchers wore the ankle foot orthosis without any motion to test the rationality of design size and wearing coordination;motion experiment without load was carried out to test the stability of transmission structure and effectiveness of motor control. The ankle foot orthosis was fixed on a table. one month No
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